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| Descriptive Information Fields | |
| Brief Title † | Study to Evaluate the Efficacy and Safety of 90Y-SMT487 in Subjects With Symptomatic Malignant Carcinoid Tumors |
| Official Title † | A Phase II Open-Label Multi-Center Study to Evaluate the Efficacy and Safety of 90Y-SMT487 in Subjects With Symptomatic Malignant Carcinoid Tumors |
| Brief Summary | Subjects will be screened to determine OctreoScan® uptake. And upon meeting the eligibility criteria, 90 subjects will complete a symptom assessment scale at baseline and throughout the study at specific time points. Actual treatment will consist of three six-week cycles of a fixed total dose of 13.3 GBq (360 mCi) of 90Y-SMT487. The total dose will be divided into three equal doses and administered as a single activity of 4.4 GBq (120 mCi) of 90Y-SMT487 once every six weeks for three cycles. An amino acid infusion will be administered along with each dose. Long-term follow up will occur at 6 and 12 months after Day 1/ Cycle 1. Survival will be assessed every six months. |
| Detailed Description | |
| Study Phase | Phase II |
| Study Type † | Interventional |
| Study Design † | Treatment, Safety/Efficacy Study |
| Primary Outcome Measure † | |
| Secondary Outcome Measure † | |
| Condition † | Malignant Carcinoid Tumor |
| Intervention † | Drug: 90Y-SMT487 |
| MEDLINE PMIDs | |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Completed |
| Enrollment † | |
| Start Date † | |
| Completion Date | |
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | |
| Administrative Information Fields | |
| NCT ID † | NCT00696930 |
| Organization ID | CSMT 487A 2202 |
| Secondary IDs †† | |
| Study Sponsor † | Molecular Insight Pharmaceuticals, Inc. |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | Molecular Insight Pharmaceuticals, Inc. |
| Verification Date | June 2008 |
| First Received Date † | June 11, 2008 |
| Last Updated Date | June 12, 2008 |